Irene, Gauteng, South Africa
Southern Implants, (Pty.) Ltd. recalls
1 recall recorded since 2018, most recently on 8 March 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 8 March 2018
- Terminated
- 26 September 2019
- Reason
- The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
- Distribution
- US, South Africa, France
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1386-2018
- SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utiliz
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.